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Philips Medizin Systeme Boeblingen GmbH

Germany · Boeblingen Baden-Wurttemberg

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Russia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

76listed device types

Class I 10Class II 66Class III 0

plus 102 registration records and 83 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

52registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 2b 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States102 registration records, 83 510(k), 0 PMA

Saudi Arabia52 confirmed, 0 excluded

Manufacturer names merged into this page: Philips Medizin Systeme Boeblingen GmbH

Same-named companies — This database also contains companies with near-identical names: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

42007

42008

52009

62010

42011

32012

52013

22014

32015

12016

32017

42018

32019

12020

22021

12022

42023

22024

62025

32026

FDA listed device types

showing 8 of 76

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1Electrocardiograph, Ambulatory (Without Analysis) 1Index-Generating Electroencephalograph Software 1Uterine Electromyographic Monitor 1Amplifier And Signal Conditioner, Transducer Signal 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252821	Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)	2026-05-29
US	K253654	IntelliVue Measurement Rack 6000 (867317)	2026-03-30
US	K252726	IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)	2026-02-06
SA	ME0000003253SFDAA00042	IntelliVue CL Charging Station	—
SA	ME0000003253SFDAA00024	M1646A PICCO Temperature Probe	—

Philips Medizin Systeme Boeblingen GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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